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Compliance testing and certification, software life cycle processes evaluation and IEC 61508 evaluations are just some of SGS’s functional safety services in relation to international standards for medical devices.

Electronic medical devices and systems are used in almost every environment where patients receive medical services – operating theatres, doctors’ surgeries, physiotherapy centres, ambulances and even in the home. These products provide data for diagnosis, and medical staff rely upon their correct operation. To ensure accuracy and consistency manufacturers need to design products that mitigate the risk of human error, poor usability or technical errors.

We offer a broad range of services to safeguard patient and operator safety.

For the European market Medical device manufacturers must demonstrate that products, software and hardware, comply with Medical Devices Directive 93/42/EEC (MDD), and the US market is regulated by the US Food and Drug Administration (US FDA). National or local authorities address different requirements for medical devices. We provide a toolbox of solutions that enable you to achieve compliance with all relevant requirements for active medical devices.

Functional Safety Services for Medical Products

Meeting the demands of this important sector, we offer a broad range of services to ensure that medical products comply with the MDD (EU). These include laboratory testing, certification and evaluation. As an accredited functional safety body, SGS also evaluates:

  • Compliance testing and certification according to IEC/EN 60601/80601 standard including general safety, EMC, usability, alarm systems, home healthcare and emergency medical services
  • Medical device software life cycle processes evaluation (IEC 62304)
  • Evaluation of compliance with IEC 61508

Software Applications

In addition, we help manufacturers of medical software applications (or ‘apps’) with the CE Conformity Declaration, in accordance with medical products regulations. Our experts provide:

  • Training on procedures and requirements of the CE Declaration of Annex VII
  • Clarification of the applicable medical device standards
  • Examination of the documents to be submitted

Bring medical devices to market with functional safety testing and certification services from SGS. Contact us today.